Year in Review: Where Spine Repair Stands Now

As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news generated by the initial publication. Here's what's happened on the vertebroplasty front since we publishedthe first 2010 piece on the topic.

In August 2009, two studies were published in the New England Journal of Medicine that contradicted overwhelming anecdotal evidence supporting vertebroplasty for the treatment of osteoporotic vertebral compression fractures.

Both found that vertebroplasty, which involves injecting a medical cement into the fracture to stabilize the bone, fared no better than a sham procedure, igniting a debate that continues to pit believers of the anecdotal evidence against adherents to evidence-based medicine.

MedPage Today last visited the debate in February, but since then, the American Academy of Orthopaedic Surgeons has issued guidelines addressing the treatment of symptomatic osteoporotic spinal compression fractures. They contain a strong recommendation against the use of vertebroplasty.

The two NEJM reports -- both considered Level I evidence because of their blinded, randomized designs -- formed the basis of the recommendation, with added support from three Level II studies that found that vertebroplasty did not relieve pain or improve function more than conservative medical therapy.

"Although I understand there's a lot of controversy I'm not sure where that controversy comes from if you look carefully at the scientific literature," Stephen Esses, MD, of Southwest Orthopedic Group in Houston, said in an interview. He was chair of the work group that crafted the guidelines.

The controversy stems from the discordant nature of the results with prior beliefs. Mountains of anecdotal evidence have convinced clinicians that vertebroplasty is a highly effective treatment for osteoporotic vertebral compression fractures.

After the two NEJM studies were published, there were numerous critiques leveled at the studies, including questions about statistical power and crossover in treatment groups, among many others.

But Esses, who has performed vertebroplasties, downplayed the criticisms. He said that if vertebroplasty is as effective as its supporters claim, then it should be easy to prove.

The Society of Interventional Radiology remains a leading critic of the studies, and stands firmly behind vertebroplasty as an effective treatment.

In a Sept. 3 letter commenting on a draft local coverage determination regarding the removal of coverage for vertebroplasty, SIR, along with the American College of Radiology, wrote, "The Society endorses the value of evidence-based medicine and randomized control trials, but we also are of the opinion that weakness in the design of these two NEJM studies, past studies indicating that vertebroplasty is effective, new research, and clinical experience need to be considered also. In sum, our position is that it is very premature -- and possibly incorrect -- to conclude that vertebroplasty is no better than a control sham procedure (trigger point, facet injection) in treating patients."

The letter pointed to results of a trial whose results were reported in August in The Lancet -- VERTOS II -- as the best data regarding vertebroplasty for symptomatic vertebral compression fractures.

The trial had an open-label, randomized design and compared vertebroplasty with conservative medical therapy. It found that the procedure resulted in significantly greater pain relief at various time points through one year.

The results came out too late to be included in the AAOS guidelines, but even if they had been included, it wouldn't have mattered, according to Esses.

That's because VERTOS II would be considered Level II as a result of the lack of blinding. Its positive results would not be enough to offset two Level I studies and three other Level II studies demonstrating a lack of benefit from vertebroplasty, Esses said.

When asked how clinicians were supposed to interpret the conflicting messages coming from the professional societies, Esses indicated that the choice was clear.

"I think that the practice of medicine today needs to be based on evidence-based medicine and science, and it's crystal clear in this particular instance of vertebroplasty -- the data do not support the use of vertebroplasty," Esses said.

However, David Kallmes, MD, of the Mayo Clinic in Rochester, Minn., stressed in an interview that more research is needed before making a final determination on the utility of vertebroplasty.

"I don't think that we should stop doing the procedures, but if we're going to do them, we should do them in the context of studies," said Kallmes, lead author of one of the NEJM studies.

Kallmes was hesitant to endorse or refute the AAOS recommendation, but, he said, "to make global statements about no longer doing the procedure based on two studies that weren't huge, I'm not sure it's the best way to go."

He said larger, prospective studies would not be hard to do, considering the number of patients who have painful compression fractures. Lack of interest and funding, however, are preventing the studies from being conducted.

Over the past year, both Esses and Kallmes have seen declines in the use of vertebroplasty at their respective centers -- although trends nationally are still unclear.

Esses said that he does not see a future for vertebroplasty, although he would not be critical of researchers who would want to perform another Level I study.

Kallmes came down strongly in support of further research.

"But I wouldn't fault anybody for applying a procedure that they think is clinically indicated with no other options for the patient. I would not say it's wrong," he said. "There's no definite answer one way or the other. It just needs to be studied."

Deyo reported that he had no conflicts of interest.

Esses reported disclosures relating to the following medical/orthopedic publications: Orthopedics, Spine, and The Spine Journal.